773830

Global Biotechnologies, Inc. — FEI 3000717683

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 16, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Portland, ME (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117421 CFR 211.42(b)Product flow through building is inadequate
139521 CFR 211.103Actual vs. theoretical yields not determined
1545321 CFR 111.16Written procedures - cleaning
1545421 CFR 111.16Written procedures - pest control
1549621 CFR 111.27(b)Instruments - calibration
1553121 CFR 111.255(a)Batch record - every batch
1564621 CFR 111.460(a)Hold, identify - in-process material
1565921 CFR 111.475(b)(1)Written procedures - holding; distributing
1573321 CFR 111.365Manufacturing operations - prevent contamination
1576321 CFR 111.205(a)Master manufacturing record - unique formulation
1580921 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
1582921 CFR 111.70(b)(1)Specifications - component identity
1583121 CFR 111.70(b)(3)Specifications - contamination limits
1583221 CFR 111.70(c)(1)In-process identity, purity, strength, composition
1585321 CFR 111.73Specifications met - identity, purity, strength, composition
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1605721 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
183321 CFR 211.84(d)(1)Identity Testing of Each Component
188521 CFR 211.165(b)Microbiological testing
191421 CFR 211.166(a)Lack of written stability program
241921 CFR 211.198(a)Complaint Handling Procedure
356121 CFR 211.56(b)Written sanitation procedures lacking
356521 CFR 211.58Buildings not maintained in good state of repair
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action